Apixaban

APIXABAN — apixaban tablet, film coated
Indoco Remedies Limited

BOXED WARNING

WARNING: (A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS
(B) SPINAL/EPIDURAL HEMATOMA
(A) PREMATURE DISCONTINUATION OF APIXABAN INCREASES THE RISK OF THROMBOTIC EVENTS
Premature discontinuation of any oral anticoagulant, including apixaban, increases the risk of thrombotic events. If anticoagulation with apixaban is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.4), Warnings and Precautions (5.1), and Clinical Studies (14.1)].

(B) SPINAL/EPIDURAL HEMATOMA
Epidural or spinal hematomas may occur in patients treated with apixaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include:

• use of indwelling epidural catheters
• concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants
• a history of traumatic or repeated epidural or spinal punctures
• a history of spinal deformity or spinal surgery
• optimal timing between the administration of apixaban and neuraxial procedures is not known

[see Warnings and Precautions (5.3)]

Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3)].

Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions (5.3)].

1 INDICATIONS & USAGE

1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation

Apixaban tablets are indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

1.2 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery

Apixaban tablets are indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

1.3 Treatment of Deep Vein Thrombosis

Apixaban tablets are indicated for the treatment of DVT.

1.4 Treatment of Pulmonary Embolism

Apixaban tablets are indicated for the treatment of PE.

1.5 Reduction in the Risk of Recurrence of DVT and PE

Apixaban tablets are indicated to reduce the risk of recurrent DVT and PE following initial therapy.

2 DOSAGE & ADMINISTRATION

2.1 Recommended Dose

Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation

The recommended dose of apixaban tablets for most patients is 5 mg taken orally twice daily.

The recommended dose of apixaban tablets is 2.5 mg twice daily in patients with at least two of the following characteristics:

• age greater than or equal to 80 years
• body weight less than or equal to 60 kg
• serum creatinine greater than or equal to 1.5 mg/dL


Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery

The recommended dose of apixaban tablets is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.
• In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days.
• In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days.


Treatment of DVT and PE

The recommended dose of apixaban tablets is 10 mg taken orally twice daily for the first 7 days of therapy. After 7 days, the recommended dose is 5 mg taken orally twice daily.

Reduction in the Risk of Recurrence of DVT and PE

The recommended dose of apixaban tablets is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE [see Clinical Studies (14.3)].

2.2 Missed Dose

If a dose of apixaban tablets is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

2.3 Temporary Interruption for Surgery and Other Interventions

Apixaban tablets should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding [see Warnings and Precautions (5.2)] . Apixaban tablets should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping apixaban tablets and prior to the intervention is not generally required. Apixaban tablets should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.

2.4 Converting from or to apixaban

Switching from warfarin to apixaban: Warfarin should be discontinued and apixaban started when the international normalized ratio (INR) is below 2.0.


Switching from apixaban to warfarin:apixaban affects INR, so that initial INR measurements during the transition to warfarin may not be useful for determining the appropriate dose of warfarin. One approach is to discontinue apixaban and begin both a parenteral anticoagulant and warfarin at the time the next dose of apixaban would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.


Switching from apixaban to anticoagulants other than warfarin (oral or parenteral):
Discontinue apixaban and begin taking the new anticoagulant other than warfarin at the usual time of the next dose of apixaban.


Switching from anticoagulants other than warfarin (oral or parenteral) to apixaban:
Discontinue the anticoagulant other than warfarin and begin taking apixaban at the usual time of the next dose of the anticoagulant other than warfarin.

2.5 Combined P-gp and Strong CYP3A4 Inhibitors

For patients receiving apixaban tablets doses of 5 mg or 10 mg twice daily, reduce the dose by 50% when apixaban tablet is coadministered with drugs that are combined P-glycoprotein (P-gp) and strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, itraconazole, ritonavir) [see Clinical Pharmacology (12.3)].

In patients already taking 2.5 mg twice daily, avoid coadministration of apixaban tablets with combined P-glycoprotein (P-gp) and strong CYP3A4 inhibitors [see Drug Interactions (7.1)].

2.6 Administration Options

For patients who are unable to swallow whole tablets, 5 mg and 2.5 mg apixaban tablets may be crushed and suspended in water, 5% dextrose in water (D5W), or apple juice, or mixed with applesauce and promptly administered orally [see Clinical Pharmacology (12.3)]. Alternatively, apixaban tablets may be crushed and suspended in 60 mL of water or D5W and promptly delivered through a nasogastric tube [see Clinical Pharmacology (12.3)].
Crushed apixaban tablets are stable in water, D5W, apple juice, and applesauce for up to 4 hours.

3 DOSAGE FORMS & STRENGTHS

  • 2.5mg, yellow, round, film coated biconvex tablets debossed with “C31” on one side and plain on the other side.
  • 5 mg, pink, oval, film coated biconvex tablets debossed with “C32″on one side and plain on the other side.

4 CONTRAINDICATIONS

Apixaban tablets are contraindicated in patients with the following conditions:

• Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions(6.1)] • Severe hypersensitivity reaction to apixaban (e.g., anaphylactic reactions) [see Adverse Reactions (6.1)]

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